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OpenTrials
Completed

NCT Number: NCT00398203

Safety and Efficacy of Using NaviAid™ BGE Device (Balloon Guided Endoscopy) For Endoscopic Diagnosis and Treatment

To assess the efficacy of the NaviAid™ BGE Device, while used in conjunction with a standard endoscope for the diagnosis and treatment of the small intestine.

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Key information

Conditions

Intestinal Diseases Digestive System Diseases Gastrointestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kings College Hospital

London, SE5 9RS, United Kingdom

About this study

Smart Medical Systems has developed the NaviAid™ Balloon Guided Endoscopy (BGE) Device, an innovative medical device for the GI tract diagnosis and treatment. The Balloon Guided Endoscopy (BGE) is a procedure intended for the examination of the small intestine, which utilizes the NaviAid™ BGE Device in conjunction with a standard endoscope.

The objectives of this prospective controlled study are to evaluate the safety and efficacy of using the NaviAid™ BGE device in the examination of the small intestine in conjunction with a standard endoscope.

Efficacy will be assessed by comparing NaviAid™ BGE Device performances to a reference Enteroscopy procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male/Female aged between 18-80 years (inclusive).
  • Subject is scheduled for endoscopic procedure after the case was reviewed by one of the investigators.
  • Symptomatic subject defined as having at least one of the following signs or symptoms:
  • Abdominal pain
  • Cramps
  • Bloating
  • Diarrhea
  • Nausea
  • Vomiting
  • Unexplained Anemia
  • GI bleeding from an unknown source
  • Small bowel abnormality on any imaging study
  • Subject able to comprehend and give informed consent for participation in this study
  • Signed Informed Consent Form

Exclusion criteria

  • Pregnancy
  • Acute bowel obstruction
  • Concomitant Coumadin or warfarin use
  • Severe diverticulitis
  • Recent (within the last 3 months) coronary ischemia or CVA (stroke)
  • Any chronic unstable disease
  • Bleeding disorders
  • Needing emergency surgery
  • Any patient condition deemed too risky for SBE by the investigator
  • Known cognitive or psychiatric disorder
  • Physician objection
  • Concurrent participation in any other clinical trial

Treatment and study plan

NaviAid™ BGE Device

Device

NaviAid™ Balloon Guided Endoscopy Device

Other names: NaviAid™ Balloon Guided Endoscopy Device

Primary outcomes

  1. Efficacy will be assessed by comparing NaviAid™ BGE Device performances to a reference Enteroscopy procedure in terms of depth of small intestine advancement and visualization.

    Time frame: Within 6 months of completion of the trial

Secondary outcomes

  1. Safety of the NaviAid™ BGE Device will be assessed by reporting adverse events, and by comparing to a reference Enteroscopy procedure.

    Time frame: Within 6 months of completion of the trial

Sponsors and collaborators

Lead sponsor

Smart Medical Systems Ltd.

Industry

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 10, 2006
Registry last updated
Jun 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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